| 1.Objective:To observe the efficacy and safety of chemotherapy combined with "Fuzheng Jiedu Quyu Method" Prescription in treatment of HER2(Human Epidermal Growth Factor Receptor 2)-negative gastric cancer through retrospective clinical studies.And to provide clinical evidence for the combination of Chinese and Western medicine comprehensive treatment strategy for HER-2 negative gastric cancer.2.Methods:Retrospective analysis of 129 patients with advanced HER-2 negative gastric cancer who were admitted to First Teaching Hospital of Tianjin University of Traditional Chinese Medicine and Tianjin Medical University Cancer Institute and Hospital from January 1,2014 to December 31,2018.Patients were divided into traditional Chinese medicine combined chemotherapy maintenance treatment group(treatment group,64 cases)and simple chemotherapy maintenance treatment group(control group,65 cases)according to the use of"Fuzheng Jiedu Quyu Method" Prescription" during the maintenance treatment.Collect clinical data of patients to compare the survival prognosis and quality of life of patients in two groups.Primary endpoint: Progress-free Survival(PFS),Secondary endpoints: Overall Survival(OS),Objective Response rate(ORR),Disease Control Rate(DCR),Karnofsky performance score(KPS score),Quality of Life,Traditional Chinese Medicine symptom score.Further explore the characteristics of the benefit population-based on patients with taking traditional Chinese medicine combined chemotherapy as maintenance treatment in patients with HER2-negative gastric cancer.3.Results:Primary endpoint: In patients with advanced HER-2 negative gastric cancer,the m PFS of patients treated with the combination of chemotherapy and "Fuzheng Jiedu Quyu Method"Prescription was 6.3 months,the m PFS of patients treated with chemotherapy maintenance was5.0 months,and the difference between the two groups of m PFS was statistically significant(P=0.033<0.05).Secondary endpoints:(1)OS: m OS was not statistically significant between two groups(11.4months in the treatment group vs.10.5 months in the control group,P=0.384>0.05).(2)Efficacy evaluation: According to the clinical evaluation among 64 patients in the treatment group there are 0 CR patients,6 PR patients,43 SD patients,15 PD patients,the ORR was 9.4%and the DCR was 76.6%;among 65 patients in the control group there are 0 CR patients,4 PR patients,39 SD patients,22 PD patients,the ORR was 6.2% and the DCR was 66.2%.There was no statistical difference in the efficacy evaluation between the two groups(P=0.382>0.05).(3)KPS score: After treatment,the KPS score of the treatment group was higher than before treatment,and the difference was statistically significant(P=0.032<0.05);the KPS score of the control group after treatment was higher than that before treatment,and the difference was not statistically significant(P=0.584>0.05).The KPS rate of return in the treatment group was higher than that in the control group(P=0.031<0.05),and the difference was statistically significant.(4)Traditional Chinese Medicine symptom score: After treatment,the treatment group was better than the control group in improving stomach pain(P=0.016<0.05),bloating(P=0.010<0.05),glouglou(P=0.009<0.05),anti-acid gas(P=0.002<0.05),nausea and vomiting(P=0.003<0.01)and poor appetite(P=0.011<0.05),and the differences was statistically different.There was no statistical difference between the two groups in terms of diarrhea(P=0.0573<0.05)and dry stool(P=0.619>0.05).64 patients of the treatment group,11 cases significantly improved,41 cases partly improved,12 cases no improvement,the total efficiency was 81.25%.65 patients of the control group,3 cases significantly improved,29 cases partly improved,33 cases no improvement,the total efficiency was 49.23%.Rank-sum test shows that P<0.01,the differences was statistically different.(5)Quality of life scale EORTC QLQ-STO22: After treatment,there is a statistically significant difference in the improvement of reflux symptoms(P=0.032<0.05)and pain(P=0.030<0.05)between the treatment group and the control group.There was no statistical difference between the two groups in terms of dysphagia(P=0.402>0.05),dietary restriction(P=0.206>0.05),anxiety(P=0.735>0.05),dry mouth(P=0.795>0.05),taste change(P=0.994>0.05),differences in body image(P=0.617>0.05),hair loss(P=0.753>0.05).(6)Safety: During the maintenance treatment,the common adverse events of the two groups included neutropenia,anemia,nausea and vomiting,diarrhea,etc.Mainly with degrees I to II.Treatment-related adverse reactions(TRAEs)of grade ≥3 in the treatment group included 2cases of neutropenia(3.1%)and 2 cases of anemia(3.1%),and TRAEs of grade ≥3 in the control group included 3 cases of neutropenia(4.6%)and 3 cases of anemia(4.6%),4 cases of nausea and vomiting(6.2%),and 1 case of diarrhea(1.5%).There were statistical differences in the incidence of adverse reactions between the two groups in terms of nausea and vomiting(P<0.01),diarrhea(P=0.012<0.05),and oral mucositis(P=0.034<0.05).There was no treatment-related death during the maintenance treatment.Kaplan-Meier univariate analysis found that the number of distant metastatic organs,the type of syndrome,the number of cycles of first-line chemotherapy,and the type of pathology are related to the prognosis of the patient.Multivariate Cox regression analysis found that the number of distant metastatic organs,the number of cycles of first-line chemotherapy,and the pathological type are independent prognostic factors that affect PFS;first-line chemotherapy<4 cycles and the number of distant metastatic organs> 2 are independent prognostic risk factors;differentiated cancer is an independent protective factor;blood stasis syndrome may be a protective factor compared with other syndrome types.4.ConclusionThe "Fuzheng Jiedu Quyu Method" prescription combined with chemotherapy for maintenance treatment of advanced HER-2 negative gastric cancer has the effect of prolonging the PFS of patients and improving the quality of life of patients.The dominant population feature may be that the number of distant metastatic organs is not more than 2 and the first-line chemotherapy cycle not less than 4 cycles,differentiated cancer,blood stasis syndrome. |
PDF Full Text Request